Surgical Ventricular Restoration

Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021

Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the “Company”), unless otherwise provided in the applicable contract. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

Services Are Considered Investigational Coverage is not available for investigational medical treatments or procedures, drugs, devices or biological products.

Based on review of available data the Company considers surgical ventricular restoration (SVR) for the treatment of ischemic dilated cardiomyopathy to be investigational.*

Policy Guidelines Surgical ventricular restoration involves increased physician work compared with standard . For example, the procedure includes evaluation of the ventricular septum and reshaping of the geometry of the . Surgical ventricular restoration is described as a global treatment of left ventricular failure, while conventional left ventricular aneurysmectomy represents a local treatment of a transmural infarct.

Background/Overview Surgical ventricular restoration is also known as surgical anterior ventricular endocardial restoration, left ventricular reconstructive surgery, endoventricular circular plasty, or the Dor procedure. Named after the surgeon who pioneered the expansion of techniques for ventricular reconstruction and is credited with treating patients with SVR and coronary artery bypass grafting.

SVR is usually performed after coronary artery bypass grafting and may precede or be followed by repair or replacement and other procedures such as endocardectomy and for treatment of ventricular tachycardia. A key difference between SVR and ventriculectomy (ie, for removal) is that, in SVR, circular “purse string” suturing is used around the border of the aneurysmal scar tissue. Tightening of this suture is believed to isolate the akinetic or dyskinetic scar, bring the healthy portion of the ventricular walls together, and restore a more normal ventricular contour. If the defect is large (ie, an opening >3 cm), the may also be reconstructed using

©2021 Blue Cross and Blue Shield of Louisiana

Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.

Page 1 of 9

Surgical Ventricular Restoration

Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021 patches of autologous or artificial material to maintain the desired ventricular volume and contour during closure of the ventriculotomy. In addition, SVR is distinct from partial left ventriculectomy which does not attempt specifically to resect akinetic segments and restore ventricular contour.

FDA or Other Governmental Regulatory Approval U.S. Food and Drug Administration (FDA) The U.S. FDA regulates the marketing of devices used as intracardiac patches through the 510(k) clearance process. These devices are Class II and are identified as polypropylene, polyethylene terephthalate, or polytetrafluoroethylene patch or pledget placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures. Biological tissue may also be a component of the patches. In 2004, the CorRestore™ ‡ Patch System (Somanetics; acquired by Medtronic) was cleared for marketing by the FDA for use “as an intracardiac patch for cardiac reconstruction and repair.” The device consists of an oval tissue patch made from glutaraldehyde- fixed bovine . It is identical to other marketed bovine pericardial patches, except that it incorporates an integral suture bolster in the shape of a ring that is used along with ventricular sizing devices to restore the normal ventricular contour. FDA product code: DXZ.

In 2020, Ancora Heart announced that it received an FDA investigational device exemption for its AccuCinch®‡ ventricular restoration system. This exemption allows Ancora Heart to proceed with an initial efficacy and safety study in patients with heart failure and reduced ejection fraction.

Rationale/Source Surgical ventricular restoration is designed to restore or remodel the left ventricle to its normal, spherical shape and size in patients with akinetic segments of the heart, secondary to ischemic dilated cardiomyopathy.

For individuals who have ischemic dilated cardiomyopathy who receive SVR as an adjunct to coronary artery bypass grafting, the evidence includes a large randomized controlled trial (another randomized controlled trial reported results, but most trial enrollees overlapped with those in the larger trial) and uncontrolled studies. The relevant outcomes are overall survival, symptoms, quality of life, hospitalizations, resource utilization, and treatment-related morbidity. The randomized controlled trial, the Surgical Treatment of Ischemic Heart Failure trial, did not report significant improvements in quality of life outcomes for patients undergoing SVR as an adjunct to standard

©2021 Blue Cross and Blue Shield of Louisiana

Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.

Page 2 of 9

Surgical Ventricular Restoration

Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021 coronary artery bypass grafting surgery. Several uncontrolled studies have suggested that SVR can improve hemodynamic functioning in selected patients with ischemic cardiomyopathy; however, these studies are considered lower quality evidence. The evidence is insufficient to determine the effects of the technology on health outcomes.

Supplemental Information Practice Guidelines and Position Statement The purpose of the Supplemental Information is to provide reference material regarding clinical input, existing practice guidelines and position statements, U.S. Preventive Services Task Force Recommendations and Medicare National Coverage Decisions and registered, ongoing clinical trials. Inclusion in the Supplemental Information does not imply endorsement or that the information is used in the evidence review.

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

European Society of and European Association for Cardio-Thoracic Surgery The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (2018; update in progress) developed joint guidelines on myocardial revascularization. The guidelines indicate that surgical ventricular restoration during coronary artery bypass grafting may be considered in selected patients treated in centers with the requisite expertise.

U.S. Preventive Services Task Force Recommendations Not applicable.

Medicare National Coverage There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers. Ongoing and Unpublished Clinical Trials Some currently ongoing trials that might influence this review are listed in Table 1.

©2021 Blue Cross and Blue Shield of Louisiana

Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.

Page 3 of 9

Surgical Ventricular Restoration

Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021

Table 1. Summary of Key Trials Planned Completion NCT No. Trial Name Enrollment Date Ongoing Assessment of Risks and Outcomes of Surgical Intervention in Patients with Ischemic Cardiomyopathy NCT04489355 260 May 2024 in the Early and Long-Term Postoperative Period, Selection of Optimal Surgical Treatment Randomized Clinical Evaluation of the AccuCinch®‡ Ventricular Restoration System in Patients Who Present NCT04331769 400 Mar 2029 With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

References 1. Blue Cross and Blue Shield Association, Medical Policy Reference Manual, “Surgical Ventricular Restoration”, 7.01.103, March 2021. 2. Jones RH, Velazquez EJ, Michler RE, et al. Coronary bypass surgery with or without surgical ventricular reconstruction. N Engl J Med. Apr 23 2009;360(17):1705-1717. PMID 19329820 3. Holly TA, Bonow RO, Arnold JM, et al. Myocardial viability and impact of surgical ventricular reconstruction on outcomes of patients with severe left ventricular dysfunction undergoing coronary artery bypass surgery: results of the Surgical Treatment for Ischemic Heart Failure trial. J Thorac Cardiovasc Surg. Dec 2014;148(6):2677- 2684 e2671. PMID 25152476 4. Oh JK, Velazquez EJ, Menicanti L, et al. Influence of baseline left ventricular function on the clinical outcome of surgical ventricular reconstruction in patients with ischaemic cardiomyopathy. Eur Heart J. Jan 2013;34(1):39-47. PMID 22584648 5. Michler RE, Rouleau JL, Al-Khalidi HR, et al. Insights from the STICH trial: change in left ventricular size after coronary artery bypass grafting with and without surgical ventricular reconstruction. J Thorac Cardiovasc Surg. Nov 2013;146(5):1139-1145 e1136. PMID 23111018 6. Kukulski T, She L, Racine N, et al. Implication of right ventricular dysfunction on long-term outcome in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting

©2021 Blue Cross and Blue Shield of Louisiana

Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.

Page 4 of 9

Surgical Ventricular Restoration

Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021

with or without surgical ventricular reconstruction. J Thorac Cardiovasc Surg. May 2015;149(5):1312-1321. PMID 25451487 7. Prior DL, Stevens SR, Holly TA, et al. Regional left ventricular function does not predict survival in ischaemic cardiomyopathy after . Heart. Sep 2017;103(17):1359-1367. PMID 28446548 8. Mark DB, Knight JD, Velazquez EJ, et al. Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial. Am Heart J. May 2009;157(5):837-844, 844 e831-833. PMID 19376309 9. Marchenko A, Chernyavsky A, Efendiev V, et al. Results of coronary artery bypass grafting alone and combined with surgical ventricular reconstruction for ischemic heart failure. Interact Cardiovasc Thorac Surg. Jun 2011;13(1):46-51. PMID 21402600 10. Athanasuleas CL, Stanley AW, Buckberg GD, et al. Surgical anterior ventricular endocardial restoration (SAVER) for dilated ischemic cardiomyopathy. Semin Thorac Cardiovasc Surg. Oct 2001;13(4):448-458. PMID 11807740 11. Athanasuleas CL, Stanley AW, Jr., Buckberg GD, et al. Surgical anterior ventricular endocardial restoration (SAVER) in the dilated remodeled ventricle after anterior myocardial infarction. RESTORE group. Reconstructive Endoventricular Surgery, returning Torsion Original Radius Elliptical Shape to the LV. J Am Coll Cardiol. Apr 2001;37(5):1199-1209. PMID 11300423 12. Mickleborough LL, Merchant N, Ivanov J, et al. Left ventricular reconstruction: Early and late results. J Thorac Cardiovasc Surg. Jul 2004;128(1):27-37. PMID 15224018 13. Bolooki H, DeMarchena E, Mallon SM, et al. Factors affecting late survival after surgical remodeling of left ventricular . J Thorac Cardiovasc Surg. Aug 2003;126(2):374-383; discussion 383-375. PMID 12928633 14. Sartipy U, Albage A, Lindblom D. The Dor procedure for left ventricular reconstruction. Ten- year clinical experience. Eur J Cardiothorac Surg. Jun 2005;27(6):1005-1010. PMID 15896609 15. Hernandez AF, Velazquez EJ, Dullum MK, et al. Contemporary performance of surgical ventricular restoration procedures: data from the Society of Thoracic Surgeons' National Cardiac Database. Am Heart J. Sep 2006;152(3):494-499. PMID 16923420 16. Tulner SA, Bax JJ, Bleeker GB, et al. Beneficial hemodynamic and clinical effects of surgical ventricular restoration in patients with ischemic dilated cardiomyopathy. Ann Thorac Surg. Nov 2006;82(5):1721-1727. PMID 17062236

©2021 Blue Cross and Blue Shield of Louisiana

Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.

Page 5 of 9

Surgical Ventricular Restoration

Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021

17. Tulner SA, Steendijk P, Klautz RJ, et al. Clinical efficacy of surgical heart failure therapy by ventricular restoration and restrictive mitral annuloplasty. J Card Fail. Apr 2007;13(3):178-183. PMID 17448414 18. Williams JA, Weiss ES, Patel ND, et al. Outcomes following surgical ventricular restoration for patients with clinically advanced congestive heart failure (New York Heart Association Class IV). J Card Fail. Aug 2007;13(6):431-436. PMID 17675056 19. Dzemali O, Risteski P, Bakhtiary F, et al. Surgical left leads to better long-term survival and exercise tolerance than coronary artery bypass grafting alone in patients with moderate ischemic cardiomyopathy. J Thorac Cardiovasc Surg. Sep 2009;138(3):663-668. PMID 19698853 20. Ohira S, Yamazaki S, Numata S, et al. Ten-year experience of endocardial linear infarct exclusion technique for ischaemic cardiomyopathy. Eur J Cardiothorac Surg. Sep 25 2017. PMID 29029034 21. Neumann FJ, Sousa-Uva M, Ahlsson A et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur. Heart J. 2019 Jan;40(2). PMID 30165437

Policy History Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021 01/04/2006 Medical Director review 01/17/2006 Medical Policy Committee review 01/26/2006 Quality Care Advisory Council approval 07/07/2006 Format revision, including addition of FDA and or other governmental regulatory approval and rationale/source. Coverage eligibility unchanged. 01/10/2007 Medical Director review 01/17/2007 Medical Policy Committee approval 01/07/2009 Medical Director review 01/14/2009 Medical Policy Committee approval. No change to coverage. 01/07/2010 Medical Policy Committee approval 01/20/2010 Medical Policy Implementation Committee approval. Coverage eligibility unchanged. 01/06/2011 Medical Policy Committee review 01/19/2011 Medical Policy Implementation Committee approval. Coverage eligibility unchanged. 03/01/2012 Medical Policy Committee review

©2021 Blue Cross and Blue Shield of Louisiana

Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.

Page 6 of 9

Surgical Ventricular Restoration

Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021

03/21/2012 Medical Policy Implementation Committee approval. Coverage eligibility unchanged. 03/07/2013 Medical Policy Committee review 03/20/2013 Medical Policy Implementation Committee approval. Coverage eligibility unchanged. 03/06/2014 Medical Policy Committee review 03/19/2014 Medical Policy Implementation Committee approval. Coverage eligibility unchanged. 03/05/2015 Medical Policy Committee review 03/20/2015 Medical Policy Implementation Committee approval.. Coverage eligibility unchanged. 08/03/2015 Coding update: ICD10 Diagnosis code section added; ICD9 Procedure code section removed. 03/03/2016 Medical Policy Committee review 03/16/2016 Medical Policy Implementation Committee approval.. Coverage eligibility unchanged. 01/01/2017 Coding update: Removing ICD-9 Diagnosis Codes 05/04/2017 Medical Policy Committee review 05/17/2017 Medical Policy Implementation Committee approval. Deleted “or postinfarction left ventricular aneurysm” from the policy statement. 05/03/2018 Medical Policy Committee review 05/16/2018 Medical Policy Implementation Committee approval. No change to coverage. 05/02/2019 Medical Policy Committee review 05/15/2019 Medical Policy Implementation Committee approval. No change to coverage. 05/07/2020 Medical Policy Committee review 05/13/2020 Medical Policy Implementation Committee approval. No change to coverage. 05/06/2021 Medical Policy Committee review 05/12/2021 Medical Policy Implementation Committee approval. No change to coverage. Next Scheduled Review Date: 05/2022

Coding The five character codes included in the Blue Cross Blue Shield of Louisiana Medical Policy Coverage Guidelines are obtained from Current Procedural Terminology (CPT®)‡, copyright 2020 by the American Medical Association (AMA). CPT is developed by the AMA as a listing of descriptive terms and five character identifying codes and modifiers for reporting medical services and procedures performed by physician.

©2021 Blue Cross and Blue Shield of Louisiana

Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.

Page 7 of 9

Surgical Ventricular Restoration

Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021

The responsibility for the content of Blue Cross Blue Shield of Louisiana Medical Policy Coverage Guidelines is with Blue Cross and Blue Shield of Louisiana and no endorsement by the AMA is intended or should be implied. The AMA disclaims responsibility for any consequences or liability attributable or related to any use, nonuse or interpretation of information contained in Blue Cross Blue Shield of Louisiana Medical Policy Coverage Guidelines. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. Any use of CPT outside of Blue Cross Blue Shield of Louisiana Medical Policy Coverage Guidelines should refer to the most current Current Procedural Terminology which contains the complete and most current listing of CPT codes and descriptive terms. Applicable FARS/DFARS apply.

CPT is a registered trademark of the American Medical Association.

Codes used to identify services associated with this policy may include (but may not be limited to) the following: Code Type Code CPT 33548 HCPCS No codes ICD-10 Diagnosis All related diagnoses

*Investigational – A medical treatment, procedure, drug, device, or biological product is Investigational if the effectiveness has not been clearly tested and it has not been incorporated into standard medical practice. Any determination we make that a medical treatment, procedure, drug, device, or biological product is Investigational will be based on a consideration of the following: A. Whether the medical treatment, procedure, drug, device, or biological product can be lawfully marketed without approval of the U.S. Food and Drug Administration (FDA) and whether such approval has been granted at the time the medical treatment, procedure, drug, device, or biological product is sought to be furnished; or B. Whether the medical treatment, procedure, drug, device, or biological product requires further studies or clinical trials to determine its maximum tolerated dose, toxicity, safety, effectiveness, or effectiveness as compared with the standard means of treatment or

©2021 Blue Cross and Blue Shield of Louisiana

Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.

Page 8 of 9

Surgical Ventricular Restoration

Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021

diagnosis, must improve health outcomes, according to the consensus of opinion among experts as shown by reliable evidence, including: 1. Consultation with the Blue Cross and Blue Shield Association technology assessment program (TEC) or other nonaffiliated technology evaluation center(s); 2. Credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community; or 3. Reference to federal regulations.

‡ Indicated trademarks are the registered trademarks of their respective owners.

NOTICE: If the Patient’s health insurance contract contains language that differs from the BCBSLA Medical Policy definition noted above, the definition in the health insurance contract will be relied upon for specific coverage determinations.

NOTICE: Medical Policies are scientific based opinions, provided solely for coverage and informational purposes. Medical Policies should not be construed to suggest that the Company recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service, or any particular course of treatment, procedure, or service.

©2021 Blue Cross and Blue Shield of Louisiana

Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.

Page 9 of 9